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Senior Associate Scientist

United States - California - Santa MonicaQualityRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Kite is seeking a highly motivated individual to join Kite as a Senior Associate Scientist to provide Quality Control oversight of Global Raw Materials and Reagents Center of Excellence.

Responsibilities include (but not limited to):

  • Develop and validate GMP test methods for raw materials.  Author and review SOPs, qualification/validation protocols, and reports. Manage method development at contract labs.
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
  • Manage creation and revision of raw materials specifications.
  • Monitor and trend data, complete routine record review of test data and related documents for raw materials release.
  • Maintain, calibrate and operate equipment and instruments supporting Raw Material Testing labs
  • Work with internal and external resources to maintain lab in an optimal state.
  • Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
  • Provide updates at daily and weekly meetings.
  • Perform other duties, including QC inspections and routine testing of raw materials
  • Represent the Global Raw Materials and Reagents Center of Excellence’s short and long term goals in cross functional task forces and collaborative efforts

Basic Qualifications:

  • MA/MS in Chemistry or Biochemistry with 4+ years’ hands-on laboratory experience in a biotech/biopharmaceutical setting OR
  • BA/BS Chemistry or Biochemistry with 6+ years’ hands-on laboratory experience in a biotech/biopharmaceutical setting OR
  • High School diploma with 10+ years’ hands-on laboratory experience in a biotech/biopharmaceutical setting

Preferred Qualifications:

  • Experience in US and International compendial methods (Visual Inspection, pH, osmolality, conductivity, endotoxin, etc.), ELISA, Gel/Western Blot, FT-IR, HPLC, PCR for materials, buffers, and reagents
  • Experience with biochemical and biophysical analytical methods:  pH, Osmolality, Conductivity, Visual Inspection, Protein assays, FT-IR, PCR, etc.
  • Experience operating in a GMP environment
  • Experience leading method development, method validation, investigations, deviations, and CAPAs
  • Exceptional oral and written communication skills
  • Ability to work independently, prioritize projects, and thrive in a dynamic environment
  • Excellent interpersonal, collaborative, and time management skills
  • Understanding of global compliance and guidance for GMP manufacturing and raw materials
  • Experience in managing cross-functional projects is a plus
  • Experience with statistical sampling methods (WHO guidelines, ANSI, etc)
  • Technical writing experience in quality records